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NCT06563856 · ClinicalTrials.gov registry record · Phase 1
A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
A Phase 1 study of Bioavailability and Bioequivalence, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT06563856: Completed Phase 1 study of Bioavailability and Bioequivalence, sponsored by Amgen.
NCT06563856 is a Phase 1 study of Bioavailability and Bioequivalence that has completed, run by Amgen. The registered enrollment target is 37 participants, roughly in line with the 34-participant average among 8 other Bioavailability trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06563856, a Phase 1 study of Bioavailability and Bioequivalence, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.
Conditions Studied
Interventions
- DRUG TEPEZZA
- DRUG EDP
Study Locations (1)
Nevada
- PPD Development - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2021-05-27 |
| Phase | Phase 1 |
What the finished NCT06563856 record still lists
NCT06563856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, roughly in line with the 34-participant average among 8 other Bioavailability trials with a reported enrollment target.
The record links to 2 conditions, with Bioavailability appearing as the primary indexed condition, and to 2 interventions - of which TEPEZZA is the first listed.
NCT06563856 reports a single indexed study location in Nevada.
Frequently Asked Questions
What is clinical trial NCT06563856 about?
NCT06563856 is a clinical study titled "A Study of TEPEZZA Subcutaneous Administration in Healthy Adults". The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.
What is the current status of trial NCT06563856?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-09-22. Estimated completion is 2021-05-27.
What conditions does trial NCT06563856 study?
This clinical trial studies the following conditions: Bioavailability, Bioequivalence.
What interventions are being tested in trial NCT06563856?
The interventions under investigation include: TEPEZZA (DRUG), EDP (DRUG).
Who is sponsoring clinical trial NCT06563856?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06563856 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06563856's enrollment target sits among peer trials
37 4th of 8 higher than 5 of 8 other Bioavailability trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bioavailability trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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